Status:
WITHDRAWN
Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques
Lead Sponsor:
First Affiliated Hospital of Harbin Medical University
Collaborating Sponsors:
Tsinghua University
Conditions:
Carotid Atherosclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The aim of this study is to assess the safety and efficacy of this technique.
Detailed Description
Carotid atherosclerotic plaque is an important cause of ischemic stroke, causes about 30% stroke/TIA attacks. Patients with carotid stenosis face an escalated risk of MI, PAD, and death. Treatments fo...
Eligibility Criteria
Inclusion
- Age 18- 80 years
- Carotid artery with 30%\~70% stenosis by ultrasound and plaque thickness\>2.5mm
- Patients without transient ischemic attack, minor stroke or amaurosis fugax within 6 months
- Patients' LDL-c level below 100 mg/dL(2.6mmol/L), well-controlled blood pressure(systolic BP\<140 and diastolic BP\<90 under resting conditions) and diabetes(HbA1c\<7%)
- Written informed consent
Exclusion
- Non-atherosclerotic carotid artery stenosis
- Contraindication to MRI( uses pacemaker, has metallic implants, claustrophobia)
- Acute MI, acute coronary syndrome or stroke within 4 weeks prior to visit or during run-in
- Severe cerebral artery stenosis, atrial fibrillation or MRI detected thrombosis that would cause stroke
- Previous significant adverse reaction to a statin
- Systemic disorders such as hepatic, renal, hematologic, and malignant disease
- Medical history that might limit the individual's ability to take trial treatments for the duration of the study
- Allergic to DVDMS or sonovue
- Diagnosis of porphyria
- Pregnant women and nursing mothers
- History of bilateral carotid endarterectomy or has immediate plans for carotid endarterectomy
- Not willing to be randomized into the 3 months trial
- Patient who is attending other clinical trial
Key Trial Info
Start Date :
September 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03382249
Start Date
September 20 2023
End Date
September 20 2023
Last Update
September 21 2023
Active Locations (1)
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1
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000